This invention relates to treatment of urinary bladder dysfunction including urinary incontinence.
U.S. Pat. No. 4,911,149 gives a background of the invention as stated in the following.
The therapeutic effects of vibratory stimulation on the human body have been documented. Vibration applied to tissue increases blood circulation due to the increase in capillary dilation. The increased blood flow increases the consumption of oxygen and nutrients by muscles and improves the regeneration process. The result is an improved muscular tone, elasticity and contractile capacity. In addition, vibratory stimulation reduces tissue swelling, enhances healing of wounds and results in effective anti-inflammatory action.
The physiological effect of low frequency vibratory stimulation varies depending on frequency, amplitude and duration of its application. Depending on the structure of the muscles (smooth or striated), the same dose of local vibratory stimulation may cause either contraction or relaxation. A low frequency mechanical vibration of between 60 and 200 Hz applied to skeletal muscle induces a sustained contraction of the muscle and a simultaneous relaxation of its prime antagonists. This tonic vibratory reflex (TVR) is elicited in normal spastic, paretic and myotonic muscles alike. Within the 60 and 200 Hz range, the vibration reduces the contractile force and tension of smooth muscle.
The most common therapeutic uses of vibratory stimulation involve external application of the vibratory forces. Vibratory stimulation is used for treating neuromuscular motor dysfunction in patients with cerebral palsy. External vibration is also used for treating patients with cervical osteochondrosis, lumbosacral radiculitiis, postamputation contracture, sequelae of lesions of the long tubular bones, and chronic dental pain. Externally applied abdominal vibration is used for improving efficiency in peritoneal dialysis and for simulating intestinal mobility in cases of intestinal atonia. External vibratory stimulation is also useful for bladder voiding in paralysed patients.
Vibratory stimulation has also been used internally to relax and dilate the cervix prior to abortion or birth. Vibration accelerates expansion of the cervical opening, thereby facilitating parturition. The vibration is applied directly to the cervical muscle, and the source of the vibration is withdrawn as soon as the cervical dilation is achieved.
Vibration sources vary with the application. External vibration may be applied by large flat or rounded vibrating machines designed to be placed against the appropriate body parts. Internal vibratory stimulation of the cervix, on the other hand, may be applied by a vibrating spatula or a vibrating bullet shaped applicator placed against the wall of the cervical muscle.
Internally applied vibratory stimulation has been proposed for treating internal muscle and connective tissue disorders such as urethral strictures, urinary and anal incontinence, unstable bladder and urethral syndrome, see U.S. Pat. No. 4,311,149 to Borodulin et al. and U.S. Pat. No. 5,782,745 to Benderev.
Externally applied penile vibratory stimulation has been used to induce ejaculation in men with spinal cord injuries, see J. Sxc3x8nksen, F. Biering-Sxc3x8rensen and J. K. Kristensen xe2x80x9cEjaculation induced by penile vibratory stimulation in men with spinal cord injuries. The importance of the vibratory amplitudexe2x80x9d, Paraplegia 32 (1994) 651-660.
Urinary incontinence is a symptom of urinary bladder dysfunction which relates to urethral sphincter dysfunction and/or abnormalities of detrusor contractions. Other conditions including for example urinary bladder hyperreflexia, urinary bladder high storage pressure, low urinary bladder capacity and urinary high flow pressure are also a part of the urinary bladder dysfunctional scenario.
Urinary incontinence is a distressing and previously neglected condition that can result from a range of pathological processes in the central or peripheral nervous system, the bladder, or the urethra. The disorder is related to faulty storage or deficient control and is difficult to treat.
Incontinence can affect all ages. Several reports have according to U.S. Pat. No. 4,911,149 shown that 16-50% of nonporous females admit to the loss of a small amount of urine during hard coughing, laughing, or sneezing, particularly if the bladder is excessively full. Five percent of women between the ages of 15-34 and about 10 to 26% in ages of 35-60 reported regular troublesome stress urinary incontinence. As is shown by both European and American researchers, urinary incontinence is a problem affecting 10 to 40% of the elderly women in the community and up to 50% of the elderly in institutions. Urinary incontinence is therefore a major geriatric problem with substantial medical and social implications.
Stress urinary incontinence is defined as the involuntary loss of urine through the intact urethra as the result of a sudden increase in intra-abdominal pressure in the absence of bladder activity. Stress urinary incontinence accounts for roughly 75% of all female urinary incontinence.
The most frequent cause of stress urinary incontinence in females is dysfunction of the sphincteric mechanism of the urethra and an inadequate pelvic floor function. The key factor in the development of stress incontinence in females is an inherent weakness in the mechanism of urinary continence upon which precipitating factors exert influence. Typically the problem occurs in women in whom childbirth causes long-term anatomic damage and a relaxation in the pelvic and periurethral musculature.
The percentage of such women comprises 52.2% of the total number of stress urinary incontinence sufferers.
Menopause is another very important precipitating factor in the development of stress incontinence. Hormonal dysfunction in postmenopausal women is characterized by estrogen deficiency and leads to atrophy of pelvic tissues. This can distort local anatomy and result in stress incontinence.
Abnormal and involuntary detrusor contractions are also a common cause of urinary frequency, urgency, nocturia, bed-wetting, urge incontinence, and the like. Abnormalities of detrusor contraction may be of neurogenic or non-neurogenic (e.g. myogenic, psychologic or idiopathic) origin. In the absence of a neurologic lesion, the condition is termed xe2x80x9cdetrusor instabilityxe2x80x9d. The unstable bladder is a very common problem affecting as much as 10% of the population and a substantially higher percentage at the two extremes of life. In most cases the aetiology of the detrusor instability remains unknown, since these patients are referred to as having xe2x80x9cidiopathicxe2x80x9d detrusor instability. As a result, the treatment of detrusor instability is difficult.
Conventional treatment of urinary incontinence falls into five main categories: surgery, drug therapy, electrical stimulation, re-education, andxe2x80x94where necessaryxe2x80x94the use of protective clothing, tampons, vaginal appliances designed to support the urethra, and indwelling catheters. These treatments are discussed below. There are over 50 surgical procedures designed to correct urinary incontinence. The success of these procedures, however, is much higher in younger women than in the elderly. Approximately 10-40% of women who undergo surgical correction of urinary stress incontinence will have recurrent urinary incontinence and other voiding difficulties. Surgery is not effective when the problem is an unstable bladder or intrinsic urethral abnormalities, and the condition of the patient after surgery in this case can worsen.
The surgical method is generally accepted as the most appropriate treatment for severe female genuine stress incontinence. In a number of cases, this method is also used for treating patients with a mild-to-moderate form of incontinence.
The trend in the profession, however, is to avoid surgical therapy if possible. In addition, there are some patients for whom surgery is inappropriate. For example, women who wish further pregnancies would be poor candidates since later vaginal deliveries may adversely affect successful surgery.
New surgical techniques such as electronic stimulation of sphincters and implantations of artificial sphincters are widely used for treating patients with urinary incontinence caused by surgical traumas or by organic neurologic dysfunctions. Although these new methods give promising results, they still require further clinical studies as well as improvements in devices necessary for implementation of these methods.
Drugs of several types also have been recommended for treating stress urinary incontinence. These drugs are non-specific, however, and therefore act on structures and viscera other than the bladder and urethra. Large doses are often required, and toxicity can easily be reached before the desired effect on the bladder and urethra is achieved. Moreover, even when drug treatment is effective, it does not lead to restoration of a normal micturition pattern.
Re-education for incontinence includes bladder retaining programs and re-education of the pelvic floor muscles. The bladder re-training method consists of instituting a program of scheduled voidings with a progressive increase in the interval between each micturition. A four to six week treatment program is common.
Two different methods of electrical stimulation for the correction of urinary incontinence are still according to U.S. Pat. No. 4,911,149 in use and are classified according to the time of application and the intensity of electrical stimuli; long-term, or chronic, electrical stimulation and short-term or maximum electrical stimulation. Long-term electrical stimulation is continued 6-20 hours daily for prolonged periods of from 3 to 36 months and short-term or maximum electrical stimulation is continued 20-30 minutes over a one-month period, the stimulation being applied 1-5 times a day. Electro-stimulation has been found to be valuable in cases of urinary urge incontinence due to detrusor instability since it is more effective than drug treatment and can produce re-education of incontinence. The mechanisms behind this curative effect are not yet defined, however.
Exercise therapy, which is a natural biological and non-invasive functional method of treatment, plays a leading role in non-surgical methods of treatment of stress urinary incontinence, as this method positively affects a weakened muscular-ligamentous apparatus of the pelvic floor. The exercise is designed to strengthen the urethral and periurethral striated muscles. Physiotherapy consists of four or five pelvic floor contractions repeated every hour and interrupted micturition practiced on each occasion. In the beginning, the treatment is carried out on a hospital basis for four weeks followed by self-treatment for a prolonged period of time.
Internal vibratory stimulation as proposed by Borodulin and Benderev always involves a certain risk for infection of the body cavities. Further it is difficult to use these methods for self-treatment.
As a rule, all the non-surgical methods of treatment of urinary incontinence described above are lengthy and require repeated courses of treatment. In addition, the long-term results of these types of treatment are largely unsuccessful. In spite of a large number of investigations dedicated to urinary incontinence, this problem is still far from being resolved.
The present invention solves significant problems in the art by providing a method for treating urinary bladder dysfunction by effective mechanical vibration or stimulation of the external genital area. By external genital area we mean clitoris and/or surroundings for women and fraenulum praeputii and/or surroundings for men. Perhaps even stimulation of perineum has an effect.
The method is useful for treating urinary bladder dysfunction caused by abnormal urinary detrusor contractions and urethral sphincter dysfunction originating from neurogenic, (e.g. spinal cord injury, scleroses and other neurogenic dysfunctions) as well as non-neurogenic (e.g. stress or urge) causes.
Repeated treatment with vibratory stimulation in spinal cord injured persons is expected to preserve kidney function due to a reduced urinary bladder storage pressure.
Furthermore, it is expected that vibratory stimulation will have similar or identical effects on urinary bladder dysfunction whether or not ejaculation/pseudoorgasm (see EXPERIMENTAL III in the following) is induced.